A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)
Completed · Phase 3
Conditions studied: Rheumatoid Arthritis
In brief
The purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).
Key facts
- Study ID
- NCT02990806
- Run by
- Nichi-Iko Pharmaceutical Co., Ltd.
- People needed
- 683
- Starts
- 2017-01-19
- Expected to finish
- 2019-05-20
- Last updated by the study team
- 2023-01-30
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with a diagnosis of rheumatoid arthritis (RA) as defined by the 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria.
- Patients have active RA, as confirmed by the following criteria:
- ≥6 swollen joints and ≥6 tender joints at screening and baseline (28-joint count).
- Either C-reactive protein (CRP) ≥0.7 mg/dL (≥7.0 mg/L) or erythrocyte sedimentation rate (ESR) ≥28 mm/h at screening.
- Patients taking methotrexate (MTX) (oral or parenteral) for at least 3 months prior to screening and at a stable dose of between 10 and 25 mg/week for at least 8 weeks. Concomitant folic/folinic acid at a dose of at least 5 mg/week is to be taken during the study; patients can start treatment with folic/folinic acid at screening if not already receiving it.
- If the patient is currently taking non-steroidal anti-inflammatory drugs (NSAIDs), the patient must be on a stable dose for at least 4 weeks prior to screening and during the study.
- Patients who are ≥18 and ≤75 years of age at screening.
You may not qualify if…
- Patients who are rated as Class IV according to the 1991 ACR revised criteria for classification of global functional status for RA.
- Patients who have received disease-modifying anti rheumatic drugs (DMARDs), other than MTX, within a period prior to screening shorter than the washout period appropriate to the pharmacodynamic profile of the specific drug.
- Patients who have received immunosuppressive drugs within 4 weeks prior to screening. Patients on a stable dose of oral corticosteroids (≤10 mg/day prednisone or equivalent) for ≥4 weeks prior to screening are permitted.
- Patients who have received intra-articular, intramuscular, intravenous, or epidural injection of corticosteroids within 4 weeks prior to screening.
- Patients who have received intra-articular sodium hyaluronate injections within 4 weeks prior to screening.
- Patients who have received surgical therapy for RA such as synovectomy or arthroplasty within 6 months prior to screening.
- Patients who have received arthrocentesis within 4 weeks prior to screening.
- Patients who have had prior treatment with infliximab.
- Patients who have had prior treatment with >1 biological drug or >1 protein kinase inhibitor for RA either as part of clinical management or during a clinical study.
- Patients who have had prior treatment with tumor necrosis factor alpha (TNF-α) inhibitors for RA who had lack of efficacy as per clinical judgment (primary failure). Patients who have discontinued TNF-α inhibitors for RA (other than infliximab) for any reason other than lack of efficacy are allowed.
- Presence of chronic or acute infection at screening, including positive result for active tuberculosis (TB).
- Patients with an acute infection requiring parenteral antibiotics within 4 weeks of study dosing or requiring oral/topical antibiotics within 2 weeks of study dosing.
Where it is running
- Nichi-Iko Investigational Site — Los Angeles, California, United States
- Nichi-Iko Investigational Site — Los Angeles, California, United States
- Nichi-Iko Investigational Site — Ventura, California, United States
- Nichi-Iko Investigational Site — Whittier, California, United States
- Nichi-Iko Investigational Site — Hamden, Connecticut, United States
- Nichi-Iko Investigational Site — Boca Raton, Florida, United States
- Nichi-Iko Investigational Site — Boynton Beach, Florida, United States
- Nichi-Iko Investigational Site — Brandon, Florida, United States
- Nichi-Iko Investigational Site — Doral, Florida, United States
- Nichi-Iko Investigational Site — Doral, Florida, United States
- Nichi-Iko Investigational Site — Hialeah, Florida, United States
- Nichi-Iko Investigational Site — Jacksonville, Florida, United States
- Nichi-Iko Investigational Site — Miami, Florida, United States
- Nichi-Iko Investigational Site — Miami, Florida, United States
- Nichi-Iko Investigational Site — Miami, Florida, United States
- Nichi-Iko Investigational Site — Miami, Florida, United States
- Nichi-Iko Investigational Site — Miami, Florida, United States
- Nichi-Iko Investigational Site — Miami, Florida, United States
- Nichi-Iko Investigational Site — Miami, Florida, United States
- Nichi-Iko Investigational Site — Miami, Florida, United States
- Nichi-Iko Investigational Site — Miami Lakes, Florida, United States
- Nichi-Iko Investigational Site — Pembroke Pines, Florida, United States
- Nichi-Iko Investigational Site — Pembroke Pines, Florida, United States
- Nichi-Iko Investigational Site — Pinellas Park, Florida, United States
- Nichi-Iko Investigational Site — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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